Concord: Lifesaving Care for Preterm Babies Improved by Keeping the Umbilical Cord Intact
Every year, 15 million infants are born preterm worldwide. Preterm birth is responsible for over 1 million deaths each year due to complications at birth, many survivors suffer from long-term disability, including learning problems, cerebral palsy or chronic lung problems.
Most preterm infants breathe insufficiently at birth, the cord is clamped immediately to not delay the respiratory support they need to survive. However, immediate cord clamping compromises the infants' cardiovascular function, which can injure its immature organs. Waiting with cord clamping until the infant has been stabilized potentially reduces complications at birth, long term disabilities and mortality.
With Concord, delayed cord clamping for preterm babies requiring lifesaving care will now be a safe option. Concord is an innovative resuscitation table that makes it possible for the neonatologist to provide all care needed to stabilize the baby, while the umbilical cord remains intact. Concord has an adjustable support bed that can be placed closely above the mother, on which the baby can be placed safely immediately after birth, to keep the sometimes very short umbilical cord intact. In addition, Concord keeps the baby close to the mother to allow bonding.
Details and State of Development:
Specialists at Leiden University Medical Center (LUMC) invented Concord and developed a clinical prototype. The prototype of Concord is used for validation of feasibility and safety in a Phase 1 clinical study. Today, 28 babies have been successfully delivered using Concord at LUMC, in the delivery room as well as in the operating room. The results are very promising regarding the feasibility and safety of the workflow, the quality of care for the baby and the very positive feedback from parents.
Concord Neonatal aims to launch a commercial product by the end of 2018. To achieve this goal, Concord Neonatal is looking for €750,000 in external investment in 3 tranches of €250,000 in 2018, 2019 and 2021.
Many cord clamping studies compared immediate cord clamping with delayed cord clamping, focusing on breathing infants:
• Fewer babies needed blood transfusions for anemia - Relative Risk (RR) 0.61
• Reduced risk of bleeding in the brain (IVH) - RR 0.6
• Reduced risk of necrotizing enterocolitis (NEC) - RR 0.62
There is now data available showing another large benefit in delaying cord clamping until ventilation has been established. Results show that waiting with cord clamping until the lung has aerated and the infant has leg stabilized leads to placental transfusion and a more stable oxygenation of the blood and a more stable heart rate during transition. This potentially decreases the injury to the infants immature organs, especially the brains and intestines.
Concord Neonatal BV was founded in April 2017 as a spin-out from LUMC, for the development and global commercialization of Concord.
- Reduce infant mortality;
- Reduce acute complications at birth;
- Reduce medical interventions
- Less days in neonatal care units
- Reduce the risk of long term disability;
- Reduce the societal economic cost of preterm birth.
Luris reference numberINV-013.085
Patent protection for the innovation has been filed worldwide, titled “Newborn support device and resuscitation device”. Concord Neonatal signed a license agreement with LUMC for exclusive rights to the patent including future improvements and innovations.